Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer

Alliance for Clinical Trials in Oncology

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: celecoxib

Drug: Celecoxib

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00045591

CDR0000256905 (Registry Identifier)

CALGB-40105

U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer

Full description

OBJECTIVES:

Primary

Compare the progression-free survival of women with metastatic or recurrent breast cancer treated with 2 dose levels of celecoxib.

Secondary

Compare the side effects of the 2 dose levels of this drug in these patients.
Compare the overall survival of patients treated with the 2 dose levels of this drug.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to disease status at study entry (complete response vs partial response vs stable) and prior metastatic/recurrent chemotherapy regimens (1 vs 2). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral high-dose celecoxib twice daily.
Arm II: Patients receive oral low-dose celecoxib twice daily. In both arms, treatment continues until first disease progression. At disease progression, treatment assignment is unblinded and treatment may continue at the treating physician's discretion. Patients initially randomized to the low-dose arm may either continue on that dosage or crossover to the high-dose arm. Patients initially randomized to the high-dose arm may continue on that dosage. Treatment after disease progression may continue for up to 12 months.

Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 132 patients (88 in the high-dose arm and 44 in the low-dose arm) will be accrued for this study within 22 months.

Enrollment

39 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed invasive breast cancer
- Metastatic or recurrent disease documented by physical or radiographic examination
- Isolated recurrence of breast cancer not considered eligible
- Bone disease alone allowed
At least 4 prior courses (or 4 months) of chemotherapy resulting in stable disease, partial response, or complete response
Treated brain metastases allowed provided all of the following conditions are met:
- Palliation achieved without evidence of progression for at least 3 months after completion of radiotherapy and/or surgical treatment
- At least 30 days since prior dexamethasone or other corticosteroids
- Documentation of another site of metastatic disease (in addition to brain metastases)
Measurable or evaluable disease
Pleural or peritoneal effusion as only manifestation of disease allowed if palliated by prior chemotherapy
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Menopausal status

Not specified

Performance status

CTC (ECOG) 0-2

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Albumin at least 3.0 g/dL

Renal

Creatinine no greater than 1.5 times ULN

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No other active malignancy within the past 2 years except nonmelanoma skin cancer
No active peptic ulcer disease
No known hypersensitivity to sulfonamides, aspirin, or other NSAIDs, including celecoxib

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent trastuzumab (Herceptin) allowed if initiated at least 3 months prior to study entry

Chemotherapy

See Disease Characteristics
At least 6 weeks since prior chemotherapy
No more than 2 prior chemotherapy regimens for recurrent or metastatic disease

Endocrine therapy

See Disease Characteristics
Prior hormonal therapy for metastatic disease allowed
No concurrent hormonal therapy except hormones for noncancer-related conditions (e.g., insulin for diabetes)

Radiotherapy

See Disease Characteristics
At least 4 weeks since prior radiotherapy
Prior radiotherapy to the breast and for metastatic disease allowed
No concurrent palliative radiotherapy

Surgery

See Disease Characteristics

Other

Prior adjuvant therapy for metastatic disease allowed
Concurrent bisphosphonates allowed
Concurrent low-dose aspirin (no greater than 325 mg/day) is allowed
No other concurrent therapy with celecoxib or other nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., rofecoxib, aspirin, choline magnesium trisalicylate, ibuprofen, naproxen, etodolac, oxaprozin, diflunisal, nabumetone, or tolmetin)
No concurrent fluconazole